Device Classification Name |
accessory, assisted reproduction |
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---|---|---|---|---|
510(k) Number | K991408 | |||
Device Name | FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR | |||
Applicant |
|
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Applicant Contact | richard l miller | |||
Correspondent |
|
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Correspodent Contact | richard l miller | |||
Regulation Number | 884.6120 | |||
Classification Product Code |
|
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Date Received | 04/22/1999 | |||
Decision Date | 07/19/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Obstetrics/Gynecology |
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510k Review Panel |
Obstetrics/Gynecology |
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summary |
summary |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |